Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Adrenaline tartrate
Laboratoire AGUETTANT
C01CA; C01CA24
Adrenaline tartrate
1 milligram/10 millilitres
Solution for injection in pre-filled syringe
Product subject to prescription which may not be renewed (A)
Adrenergic and dopaminergic agents; epinephrine
Marketed
2016-03-11
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ADRENALINE (EPINEPHRINE) 1 MG/10 ML (1:10,000), SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE (Referred to as ‘Adrenaline (Epinephrine) injection’ in this leaflet) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Adrenaline (Epinephrine) injection is and what it is used for 2. What you need to know before you are given Adrenaline (Epinephrine) injection 3. How Adrenaline (Epinephrine) injection is given 4. Possible side effects 5. How to store Adrenaline (Epinephrine) injection 6. Contents of the pack and other information 1. WHAT ADRENALINE (EPINEPHRINE) INJECTION IS AND WHAT IT IS USED FOR Adrenaline (Epinephrine) Injection belongs to a group of medicines called adrenergic and dopaminergic agents. THIS MEDICINE IS USED FOR: - Treatment of cardiac arrest (unexpected loss of heart function, breathing and consciousness), - Treatment of acute anaphylaxis in adults (serious shock or collapse produced by a severe allergic reaction). 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ADRENALINE (EPINEPHRINE) INJECTION YOU MUST NOT BE GIVEN ADRENALINE (EPINEPHRINE) INJECTION • If you are allergic (hypersensitive) to any ingredients of this medicine (listed in section 6) where an alternative presentation of Adrenaline or alternative vasopressor is available. WARNINGS AND PRECAUTIONS Adrenaline (Epinephrine) injection is indicated for emergency treatment. Continuous medical supervision is necessary after administration. PRECAUTIONS FOR USE The ri Läs hela dokumentet
Health Products Regulatory Authority 05 October 2022 CRN00D5GN Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adrenaline (Epinephrine) 1 mg/10 ml (1:10,000) Solution for Injection in Pre-Filled Syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for injection contains 0.1 mg of adrenaline (epinephrine) (as adrenaline (epinephrine) tartrate). Each 10 ml pre-filled syringe contains 1 mg adrenaline (epinephrine) (as adrenaline (epinephrine) tartrate). Excipient with known effect: sodium Each ml of solution for injection contains 3.54 mg equivalent to 0.154 mmol of sodium. Each 10 ml pre-filled syringe contains 35.4 mg equivalent to 1.54 mmol of sodium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection in pre-filled syringe Clear and colourless solution in a 10 ml pre-filled syringe pH = 3.0 to 3.4 Osmolarity: 270 – 300 mOsm/l 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cardiopulmonary resuscitation Acute anaphylaxis in adults 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Intravenous adrenaline should only be administered by those experienced in the use and titration of vasopressors in their normal clinical practice. _CARDIOPULMONARY RESUSCITATION:_ 10 ml of the 1:10,000 solution (1mg) by the intravenous or intraosseous route, repeated every 3-5 minutes until return of spontaneous circulation. Endotracheal use should only be considered as a last resort if no other route of administration is accessible, at a dose of 20 to 25 ml of the 1:10,000 solution (2 to 2.5 mg). In cardiac arrest following cardiac surgery, Adrenaline should be administered intravenously in doses of 0.5 ml or 1ml of 1:10,000 solution (50 or 100 micrograms) very cautiously and titrated to effect. ACUTE ANAPHYLAXIS Titrate using intravenous boluses of 0.5 ml 1:10,000 solution (0.05 mg) according to response. Adrenaline 1 mg/10 ml (1:10,000) solution for injection in pre-filled syringe is not recommended for intramuscular use in acute anaphylaxis. For i Läs hela dokumentet